Skip to main content
Sister Publication Links
  • ESG: THE NEW IMPERATIVE
Subscribe
  • My Account
  • Login
  • Subscribe
  • News
    • Current News
    • COVID-19
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Transformation
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Digital Health
  • Insights
    • ACA 10 Years After
    • Best Practices
    • Special Reports
    • Innovations
  • Data/Lists
    • Rankings/Lists
    • Interactive Databases
    • Data Points
  • Opinion
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Custom Media Event: ESG Summit
    • Webinars
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Diversity in Healthcare
      • - Luminaries
      • - Top 25 Diversity Leaders
      • - Leaders to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Leadership Symposium
    • Social Determinants of Health Symposium
    • Transformation Summit
    • Women Leaders in Healthcare Conference
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Diversity Leaders Gala
    • Top 25 Women Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Supply Chain Revenue Cycle
    • - Hospital at Home
    • - Workplace of the Future
    • - Virtual Health
    • - Future of Healthcare Staffing
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
  • MORE +
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Providers
January 15, 2016 12:00 AM

Olympus to begin voluntary recall of its duodenoscopes

Steven Ross Johnson
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print

    The U.S. Food and Drug Administration has approved medical-device maker Olympus' redesigned duodenoscopes. The agency said the changes aim to lower the risk of infections through contamination.

    In February, Olympus will begin recalling its TJF-Q180V model duodenoscope from an estimated 4,400 healthcare facilities.

    Scopes made by Olympus and other manufacturers have been linked to 25 infection incidents between 2012 and 2015 in the U.S., where as many as 250 patients acquired antibiotic-resistant infections, according to a Senate committee minority staff report released this week.

    Modifications to Olympus' scope aim to prevent leaking believed to increase infection risk.

    The FDA notified Olympus in March 2014 that it would have to apply for approval of modifications it had made without first notifying the federal agency. Olympus submitted an application for approval in October.

    “We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” Dr. William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in a written statement.

    In August, the FDA cited Olympus, along with fellow devicemakers Fujifilm and Pentax parent company Hoya Corp., with failures in the production of the devices. The agency said the companies also failed to properly handle reports of adverse events.

    And last October, regulators ordered all three companies to conduct post-market research on how effective their disinfecting instructions for those devices were in a medical setting. Hospitals where infections associated with the scopes took place argue the manufacturers didn't provide solid instructions on how to disinfect the scopes.

    The devices are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures annually in the U.S. The procedure is a minimally invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.

    The FDA has maintained the benefits of ERCPs outweigh the potential risk of contamination from the endoscopes. But the agency acknowledged the device's complex design made the risk of contamination possible even when cleaning instructions were correctly followed.

    “Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the agency stated in an alert issued in February.

    Olympus is expected to send out notices on Friday to facilities that own the TJF-Q180V model. The letter will offer instructions on returning the device free of charge. The company estimates a four-day turnaround to make the changes.

    The FDA advises healthcare facilities can continue to use the Olympus TJF-Q180V model while they wait for the repairs, but caution to strictly follow the manufacturer's reprocessing instructions.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    U.S.-medical-tourism
    COVID-19 pandemic dents medical tourism revenue
    colorful-people_i_i.png
    The Joint Commission to add health equity standards to accreditations
    Sponsored Content
    Modern Healthcare A.M. Newsletter: Sign up to receive a comprehensive weekday morning newsletter designed for busy healthcare executives who need the latest and most important healthcare news and analysis.
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2022. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • COVID-19
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Digital Health
    • Insights
      • ACA 10 Years After
      • Best Practices
      • Special Reports
      • Innovations
    • Data/Lists
      • Rankings/Lists
      • Interactive Databases
      • Data Points
    • Opinion
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Excellence in Governance
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top 25 Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Transformation Summit
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Supply Chain Revenue Cycle
        • - Hospital at Home
        • - Workplace of the Future
        • - Virtual Health
        • - Future of Healthcare Staffing
      • Custom Media Event: ESG Summit
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • MORE +
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing